Skip to main content

Main menu

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN

User menu

Search

  • Advanced search
CMAJ
  • CMAJ JOURNALS
    • CMAJ Open
    • CJS
    • JAMC
    • JPN
CMAJ

Advanced Search

  • Home
  • Content
    • Current issue
    • Past issues
    • Early releases
    • Collections
    • Sections
    • Blog
    • Infographics & illustrations
    • Podcasts
    • COVID-19 articles
    • Obituary notices
  • Authors & Reviewers
    • Overview for authors
    • Submission guidelines
    • Submit a manuscript
    • Forms
    • Editorial process
    • Editorial policies
    • Peer review process
    • Publication fees
    • Reprint requests
    • Open access
    • Patient engagement
  • Physicians & Subscribers
    • Benefits for Canadian physicians
    • CPD Credits for CMA Members
    • Subscribe to CMAJ Print
    • Subscription prices
    • Obituary notices
  • Alerts
    • Email alerts
    • RSS
  • JAMC
    • À propos
    • Numéro en cours
    • Archives
    • Sections
    • Abonnement
    • Alertes
    • Trousse média 2023
    • Avis de décès
  • Visit CMAJ on Facebook
  • Follow CMAJ on Twitter
  • Follow CMAJ on Instagram
  • Listen to CMAJ podcasts
Practice

Paroxetine (Paxil) and congenital malformations

Megan Williams and Eric Wooltorton
CMAJ November 22, 2005 173 (11) 1320-1321; DOI: https://doi.org/10.1503/cmaj.051421
Megan Williams
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Eric Wooltorton
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Tables
  • Related Content
  • Responses
  • Metrics
  • PDF
Loading

Reason for posting: Selective serotonin reuptake inhibitors (SSRIs) have not previously been demonstrated, as a group, to be teratogenic.1 However, the results of an unpublished study2 by GlaxoSmithKline (GSK) has led the US Food and Drug Administration and Health Canada to warn that one SSRI, paroxetine, may increase the risk of major congenital malformations.3

The drug: Antidepressants, including paroxetine, are used to treat major depression, anxiety, obsessive–compulsive disorder and premenstrual dysphoria, all common disorders during the childbearing years.4 GSK, the manufacturer of paroxetine and another antidepressant, bupropion, recently completed an unpublished retrospective study of data from 2 US managed-care insurance databases. Pregnancy outcomes among 3581 expectant mothers aged 12– 49 years who were taking antidepressants were studied.

Initially, the study sought to investigate whether women prescribed buproprion had infants with higher rates of cardiovascular malformations than women either taking other antidepressants or taking the drug in the third trimester only. Any cardiac or serious congenital malformation was recorded for users of bupropion in the first or third trimester and users of any other antidepressants. The analysis excluded women with concurrent first-trimester use of known teratogens, including lithium, valproic acid and carbamazepine.

Children exposed to bupropion in the first or third trimester did not have increased rates of malformations relative to those taking any antidepressant. The FDA, however, requested a secondary analysis of specific rates of malformations among infants of users of all other antidepressants. There were 18 used in total, including SSRIs, tricyclics, serotonin–norepinephrine-reuptake inhibitors and other new antidepressants.

Only users of paroxetine had an increased risk of malformations higher than those of other antidepressants (Table 1). Various organ systems (gastrointestinal, genitourinary and central nervous system) were affected in roughly equal proportions. The most common cardiovascular malformations seen were ventricular septal defects.2

View this table:
  • View inline
  • View popup
  • Download powerpoint

Table 1.

The absolute rate of major congenital seen in the first trimester for paroxetine users was 4%; of cardiovascular malformations, 2%.3 This study did not include controls of women not taking an antidepressant; however, the prevalence of major congenital and cardiovascular malformations for all births in the United States, regardless of drug exposure, are 3% and 1%, respectively.3

What to do: This study is limited by its retrospective design, its post hoc secondary analyses, the limited clinical details available in an insurance database, and its lack of controls. However, it is one of the first reasonably large epidemiologic studies to suggest possible teratogenicity of an SSRI. Why paroxetine may have this effect is not clear, and the results conflict with other epidemiologic studies performed to date.3 Although the relative risk increase of malformations is about twofold, the absolute risk increase over baseline malformation rates appears to be about 1% (i.e., about 100 pregnant users would be needed before additional harm would come to one infant). Any woman of childbearing age being treated with paroxetine should be counselled on these absolute and relative risks. If pregnancy is a real possibility, consideration should be given to switching medications.

Footnotes

  • Competing interests: None declared.

REFERENCES

  1. 1.↵
    Einarson TR, Einarson A. Newer antidepressants in pregnancy and rates of major malformations: a meta-analysis of prospective comparative studies. Pharmacoepidemiol Drug Saf 2005;Mar 1 [Epub ahead of print]. DOI:10.1002/pds.1084
  2. 2.↵
    GlaxoSmithKline study EPIP083. GSK medicine: bupropion and paroxetine. Epidemiology study: preliminary report on bupropion in pregnancy and the occurrence of cardiovascular and major congenital malformation. Available: http://ctr.gsk.co.uk/summary/paroxetine/epip083.pdf (accessed 2005 Oct 26); also archived at www.cmaj.ca/cgi/content/full/173/11/1320/DC1 as an appendix.
  3. 3.↵
    Dillon AJ, for GlaxoSmithKline Inc., encorsed by Health Canada. New safety information regarding paroxetine. Findings suggest increased risk over other antidepressants, of congenital malformations, following first trimester exposure to paroxetine [Dear Health Care Professional letter]. Available: www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/paxil_3_hpc-cps_e.html (accessed 2005 Oct 26).
  4. 4.↵
    Hallberg P, Sjoblom V. The use of selective serotonin reuptake inhibitors during pregnancy and breast-feeding: a review and clinical aspects [review]. J Clin Psychopharmacol 2005;25:59-73.
    OpenUrlCrossRefPubMed
PreviousNext
Back to top

In this issue

Canadian Medical Association Journal: 173 (11)
CMAJ
Vol. 173, Issue 11
22 Nov 2005
  • Table of Contents
  • Index by author

Article tools

Respond to this article
Print
Download PDF
Article Alerts
To sign up for email alerts or to access your current email alerts, enter your email address below:
Email Article

Thank you for your interest in spreading the word on CMAJ.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Paroxetine (Paxil) and congenital malformations
(Your Name) has sent you a message from CMAJ
(Your Name) thought you would like to see the CMAJ web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Paroxetine (Paxil) and congenital malformations
Megan Williams, Eric Wooltorton
CMAJ Nov 2005, 173 (11) 1320-1321; DOI: 10.1503/cmaj.051421

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
‍ Request Permissions
Share
Paroxetine (Paxil) and congenital malformations
Megan Williams, Eric Wooltorton
CMAJ Nov 2005, 173 (11) 1320-1321; DOI: 10.1503/cmaj.051421
Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
    • Footnotes
    • REFERENCES
  • Figures & Tables
  • Related Content
  • Responses
  • Metrics
  • PDF

Related Articles

  • PubMed
  • Google Scholar

Cited By...

  • A systematic review and meta-analysis considering the SSRI, SNRI and TCA classes of antidepressants and the risk for congenital heart defects
  • Persistent pulmonary hypertension of the newborn and maternal use of SSRIs
  • Google Scholar

More in this TOC Section

  • Topical nonsteroidal anti-inflammatory drugs
  • Postcoital bleeding
  • Phlegmonous gastritis
Show more Practice

Similar Articles

Collections

  • Topics
    • Congenital heart disease
    • Drugs: adverse reactions
    • Drugs: psychotherapeutic

 

View Latest Classified Ads

Content

  • Current issue
  • Past issues
  • Collections
  • Sections
  • Blog
  • Podcasts
  • Alerts
  • RSS
  • Early releases

Information for

  • Advertisers
  • Authors
  • Reviewers
  • CMA Members
  • CPD credits
  • Media
  • Reprint requests
  • Subscribers

About

  • General Information
  • Journal staff
  • Editorial Board
  • Advisory Panels
  • Governance Council
  • Journal Oversight
  • Careers
  • Contact
  • Copyright and Permissions
CMAJ Group

Copyright 2023, CMA Impact Inc. or its licensors. All rights reserved. ISSN 1488-2329 (e) 0820-3946 (p)

All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association or its subsidiaries.

To receive any of these resources in an accessible format, please contact us at CMAJ Group, 500-1410 Blair Towers Place, Ottawa ON, K1J 9B9; p: 1-888-855-2555; e: [email protected]

CMA Civility, Accessibility, Privacy

 

Powered by HighWire